FDA recall, , Moderate risk
OrthAlign Lantern Knee System Drill Plates
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).
Summary by Recall Canary from the FDA notice
What happened
Orthalign, Inc. of Aliso Viejo, California recalled Drill Plate components of the Lantern Knee System, including the Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 and the Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1-5 REF:402566, because drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).
The recall began February 10, 2026, and was added to the FDA's Enforcement Report on March 24, 2026, with distribution in the state of Utah.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
- UDI-DI
- 00810832032434
- Lot code
- 25092204BB
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
- UDI-DI
- 00810832032427
- Lot code
- 25091103BB
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Utah.
- Company
- Orthalign, IncAliso Viejo, California
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98516
- Recall numbers
- Z-1629-2026 to Z-1630-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
